Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes

NCT ID: NCT01684956

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-12-31

Brief Summary

The investigators are doing this research study to find out if the type of needle used to administer them affects the speed with which insulin and glucagon get into the blood. The investigators will compare a traditional insulin needle to an injection device, called the MicronJet, that uses microneedles to deliver medication into the top layer of your skin.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intradermal first

Intradermal injection experiment first, followed by subcutaneous injection experiment

Group Type: EXPERIMENTAL

Intradermal injection

Intervention Type: PROCEDURE

Subcutaneous injection

Intervention Type: PROCEDURE

Subcutaneous first

Subcutaneous injection experiment first, followed by intradermal injection experiment

Group Type: EXPERIMENTAL

Intradermal injection

Intervention Type: PROCEDURE

Subcutaneous injection

Intervention Type: PROCEDURE

Interventions

Intradermal injection

Intervention Type: PROCEDURE

Subcutaneous injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older with clinical type 1 diabetes for at least one year
• Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (Novolog), insulin lispro (Humalog), and insulin glulisine (Apidra).
• Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 5 units of rapid acting insulin
• Stimulated C-peptide <0.1 nmol/L at 90 minutes after liquid mixed meal tolerance test.

Exclusion Criteria

• Unable to provide informed consent
• Unable to comply with study procedures
• Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Potential subjects enrolled in trails of passive monitoring equipment, such as continuous glucose monitors (CGMs), are not excluded
• Inadequate venous access as determined by study nurse or physician at time of screening
• Pregnancy
• Hemoglobin less than 13.5 for men and less than 12 for women
• History of pheochromocytoma (fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor to include episodic or treatment refractory hypertension defined as requiring 4 or more medications to achieve normotension, paroxysms of tachycardia, pallor, or headache, or personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease)
• History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
• History of adrenal disease or tumor
• Hypertension (blood pressure > 160/100 mm/Hg at screening or day of study visit
• History of allergy to aspirin or any history of aspirin intolerance, including Reye's syndrome, or gastric ulcer or bleeding associated with salicylates.
• Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrand's disorder, and idiopathic thrombocytopenic purpura (ITP)
• Peptic Ulcer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Russell, MD, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven J Russell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2012P001098

Identifier Type: -

Identifier Source: org_study_id